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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSILIKON 1000 RETINAL TAMPONADE
Generic NameFluid, intraocular
Regulation Number886.4275
ApplicantALCON
6201 SOUTH FREEWAY
MAIL DROP R7-14
FORT WORTH, TX 76134-2099
PMA NumberP950008
Supplement NumberS011
Date Received10/22/2013
Decision Date11/22/2013
Product Code LWL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATE REAGENT SUPPLIER.
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